EP2952178A1 - Compositions ophtalmiques et procédés pour le traitement des yeux - Google Patents

Compositions ophtalmiques et procédés pour le traitement des yeux Download PDF

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Publication number
EP2952178A1
EP2952178A1 EP15176046.9A EP15176046A EP2952178A1 EP 2952178 A1 EP2952178 A1 EP 2952178A1 EP 15176046 A EP15176046 A EP 15176046A EP 2952178 A1 EP2952178 A1 EP 2952178A1
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EP
European Patent Office
Prior art keywords
composition
component
components
metal
eye
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP15176046.9A
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German (de)
English (en)
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EP2952178B1 (fr
Inventor
Joseph G. Vehige
Peter A. Simmons
Joan-En Chang-Lin
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Allergan Inc
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Allergan Inc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36218032&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP2952178(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Allergan Inc filed Critical Allergan Inc
Priority to EP20193341.3A priority Critical patent/EP3777836A1/fr
Publication of EP2952178A1 publication Critical patent/EP2952178A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/14—Quaternary ammonium compounds, e.g. edrophonium, choline
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/717—Celluloses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • A61K38/1732—Lectins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/04—Artificial tears; Irrigation solutions

Definitions

  • betaine trimethyl glycine
  • taurine is accumulated by ocular cells under hypertonic conditions.
  • ophthalmic compositions comprising a carrier, for example, an aqueous carrier, component, and an effective amount of a material selected from inositol components, xylitol components and mixtures thereof.
  • a carrier for example, an aqueous carrier, component, and an effective amount of a material selected from inositol components, xylitol components and mixtures thereof.
  • the osmolality of such compositions are often higher or greater than isotonic, for example, in a range of at least 310 to about 600 or about 1000 mOsmols/kg.
  • the duration of clinical benefit resulting from each dosage or application is increased.
  • ocular surface health is enhanced as cells are less metabolically challenged and cell survival is enhanced.
  • the buffer salts include alkali metal, alkaline earth metal and/or ammonium salts, as well as citrate, phosphate, borate, lactate and the like salts and mixtures thereof.
  • Conventional organic buffers such as Goode's buffer and the like, may also be employed.
  • the amount or concentration of such electrolyte component in the present compositions can vary widely and depends on various factors, for example, the specific electrolyte component being employed, the specific composition in which the electrolyte is to be included and the like factors.
  • the amount of the electrolyte component is chosen to at least partially resemble, or even substantially resemble, the electrolyte concentration in natural human tears.
  • the concentration of the electrolyte component is in the range of about 0.01 to about 0.5 or about 1% of the present composition.
  • a solution of the polyanionic component portions and purified water is obtained, as noted above.
  • This solution is then sterilized, for example, as noted above.
  • the other components to be included in the final composition are solubilized in purified water.
  • This latter solution is sterile filtered, for example, through a 0.2 micron sterilizing filter, such as that sold by Pall under the tradename Suporflow, into the polyanionic component-containing solution to form the final solution.
  • the final solution is filtered, for example, as noted above, to provide a clear, smooth solution which is then aseptically filled into containers, as noted above.
  • JNK1 and JNK2 The intensity of each of JNK1 and JNK2 was tested for each of these compositions using Western blot analysis with specific antibodies to each phosphorylated species.
  • the patient has reduced pain and/or reduced discomfort and/or reduced eye irritation and/or more rapid recovery from the surgical procedure relative to undergoing an identical surgical procedure including being administered the same composition without the polypeptide analog.
  • Purite® is a registered trademark of Allergan, Inc. for stabilized chlorine dioxide. This material is added to the mixture after heat sterilization.
  • Example 10 The procedure of Example 10 is repeated to provide the following compositions.
  • Ingredient Concentration, % (w/v) A B C D Carboxy Methylcellulose (CMC) 1.0 - - 0.5 Glycerol 0.5 0.5 - 0.5 Carnitine 0.25 0.25 0.75 0.75 Boric Acid 0.60 0.60 0.60 0.60 Sodium Borate Decahydrate 0.045 0.045 0.045 0.045 Calcium Chloride Dihydrate 0.006 0.006 0.006 0.006 Magnesium Chloride Hexahydrate 0.006 0.006 0.006 Purite® (1) 0.0075 0.0075 0.075 0.075 Sodium Hydroxide 1N Adjust pH to 7.2 Adjust pH to 7.2 Adjust pH to 7.2 Adjust pH to 7.2 Adjust pH to 7.2 Adjust pH to 7.2 Adjust pH to 7.2 Adjust pH to 7.2 Purified water q.s.
  • CMC Carboxy Methylcellulose
  • Example 10 The procedure of Example 10 is repeated to provide the following compositions.
  • Ingredient Concentration, % (w/v) A B C D Carboxy Methylcellulose (CMC) 1.0 - - 0.5 Glycerol 0.5 0.5 - 0.5 Betaine (2) 0.25 0.25 0.75 0.75 Boric Acid 0.60 0.60 0.60 0.60 Sodium Borate Decahydrate 0.045 0.045 0.045 0.045 Calcium Chloride Dihydrate 0.006 0.006 0.006 0.006 0.006 Magnesium Chloride Hexahydrate 0.006 0.006 0.006 Purite® (1) 0.0075 0.0075 0.075 0.075 Sodium Hydroxide 1N Adjust pH to 7.2 Adjust pH to 7.2 Adjust pH to 7.2 Adjust pH to 7.2 Adjust pH to 7.2 Adjust pH to 7.2 Adjust pH to 7.2 Adjust pH to 7.2 Purified water q.
  • CMC Carboxy Methylcellulose
  • Purite® is a registered trademark of Allergan, Inc. for stabilized chlorine dioxide. This material is added to the mixture after heat sterilization.
  • Betaine is found to be incompatible with the Purite7 preservative. Therefore, no preservative is used. These compositions are useful in single or unit dose applications.
  • compositions produced in Examples 10 through 16 in the form of eye drops, is administered once a day or more often to the eyes of a patient suffering from dry eye syndrome. Administration may be either in response to or in anticipation of exposure to adverse environmental conditions for example dry or windy environments, low humidity, extensive computer use, and the like. Such administration is substantially similar to that used with conventional artificial tear compositions.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
EP15176046.9A 2004-11-16 2005-11-14 Compositions ophtalmiques et procédés pour le traitement des yeux Expired - Lifetime EP2952178B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP20193341.3A EP3777836A1 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques et procédés pour le traitement des yeux

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/990,811 US8569367B2 (en) 2004-11-16 2004-11-16 Ophthalmic compositions and methods for treating eyes
PCT/US2005/041064 WO2006055454A2 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques et procedes de traitement oculaire
EP05821259.8A EP1811959B2 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
EP05821259.8A Division-Into EP1811959B2 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques
EP05821259.8A Division EP1811959B2 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques

Related Child Applications (1)

Application Number Title Priority Date Filing Date
EP20193341.3A Division EP3777836A1 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques et procédés pour le traitement des yeux

Publications (2)

Publication Number Publication Date
EP2952178A1 true EP2952178A1 (fr) 2015-12-09
EP2952178B1 EP2952178B1 (fr) 2020-09-02

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ID=36218032

Family Applications (4)

Application Number Title Priority Date Filing Date
EP20193341.3A Withdrawn EP3777836A1 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques et procédés pour le traitement des yeux
EP20100185764 Expired - Lifetime EP2422765B1 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques et procédés pour le traitement des yeux
EP05821259.8A Expired - Lifetime EP1811959B2 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques
EP15176046.9A Expired - Lifetime EP2952178B1 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques et procédés pour le traitement des yeux

Family Applications Before (3)

Application Number Title Priority Date Filing Date
EP20193341.3A Withdrawn EP3777836A1 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques et procédés pour le traitement des yeux
EP20100185764 Expired - Lifetime EP2422765B1 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques et procédés pour le traitement des yeux
EP05821259.8A Expired - Lifetime EP1811959B2 (fr) 2004-11-16 2005-11-14 Compositions ophtalmiques

Country Status (23)

Country Link
US (11) US8569367B2 (fr)
EP (4) EP3777836A1 (fr)
JP (1) JP5179880B2 (fr)
KR (1) KR101344602B1 (fr)
CN (1) CN101056618B (fr)
AR (1) AR052031A1 (fr)
AU (2) AU2005306721B2 (fr)
BR (2) BRPI0518173B8 (fr)
CA (1) CA2588044C (fr)
CY (2) CY1116545T1 (fr)
DK (3) DK1811959T4 (fr)
ES (3) ES2543974T3 (fr)
HU (2) HUE026575T2 (fr)
IL (1) IL182532A (fr)
NO (3) NO347855B1 (fr)
NZ (2) NZ597106A (fr)
PL (3) PL218364B1 (fr)
PT (2) PT1811959E (fr)
RU (1) RU2410081C2 (fr)
SI (2) SI1811959T2 (fr)
TW (1) TWI369996B (fr)
WO (1) WO2006055454A2 (fr)
ZA (1) ZA200702917B (fr)

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US20140256675A1 (en) 2014-09-11
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US20130190398A1 (en) 2013-07-25
US10213405B2 (en) 2019-02-26
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CA2588044A1 (fr) 2006-05-26
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US20140045773A1 (en) 2014-02-13
US9668997B2 (en) 2017-06-06
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EP1811959B1 (fr) 2015-09-02
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US20160256424A1 (en) 2016-09-08
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US9254324B2 (en) 2016-02-09
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